BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IRM INC.

    Reg #: 3014055202 · FEI: 3014055202 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IRM INC.
    Registration Number
    3014055202
    FEI Number
    3014055202
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8th-2, HongWoo Bldg, 15, Yeoksam-ro 8-gil, Gangnam-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K201296

    Owner / Operator

    Firm Name
    IRM Inc.
    Operator Number
    10055970
    Address
    8th-2, HongWoo Bldg, 15, Yeoksam-ro 8-gil, Gangnam-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    06250
    Country
    KR
    Correspondent
    YunIk Kim

    US Agent

    Business Name
    IRM Healthcare Inc.
    Contact Name
    Julian Lee
    Address
    11900 NE 1st St, Ste 300, Rm 3094
    City
    Bellevue
    State
    WA
    ZIP
    98005
    Country
    US
    Email
    [email protected]
    Phone
    510 8210056

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    i-Rapha Solution I-Rapha View

    Establishment Types

    Manufacture Medical Device